Skip to main content
OpenTrials
Completed

NCT Number: NCT04439383

Risk Stratification for Venous Thromboembolism in Hospitalized Medical Patients

Hospital-acquired venous thromboembolism (HA-VTE) is one of the leading preventable causes of in-hospital mortality, but prevention of VTE in hospitalized medical patients remains challenging, as preventive measures such as pharmacological thromboprophylaxis (TPX) need to be tailored to individual thrombotic risk.

The broad objective of this project is to improve VTE prevention strategies in hospitalized medical patients by prospectively examining VTE risk factors (including mobility) and comparing existing risk assessment models.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Deep Vein Thrombosis Disease Attributes Embolism Embolism and Thrombosis Hospital Acquired Condition Iatrogenic Disease Lung Diseases Mobility Limitation Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Embolism Respiratory Tract Diseases Signs and Symptoms Thromboembolism Thrombosis Vascular Diseases Venous Thromboses Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospital, Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Admitted for hospitalization >24 hours on a general internal medicine ward
  • Informed consent as documented by signature

Exclusion criteria

  • Need for therapeutic anticoagulation (e.g., atrial fibrillation)
  • Life expectancy <30 days
  • Insufficient proficiency of the German or French language
  • Unwilling to provide informed consent
  • Prior enrolment in the study

Treatment and study plan

Primary outcomes

  1. Venous thromboembolism

    Time frame: Within 90 days of initial hospital admission

    Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism after hospital admission

Secondary outcomes

  1. Venous thromboembolism

    Time frame: During the initial hospitalization, an average of 7 days

    Symptomatic, objectively confirmed fatal and non-fatal hospital-acquired venous thromboembolism, including symptomatic distal and proximal deep vein thrombosis and pulmonary embolism during hospitalization

  2. All-cause mortality

    Time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

    All-cause mortality (all causes of death will be considered)

  3. Major bleeding

    Time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

    Major bleeding will be defined as fatal bleeding, symptomatic bleeding at critical sites (intracranial, intraspinal, intraocular, retroperitoneal, intraarticular, pericardial, or intramuscular with compartment syndrome), or bleeding with a reduction of hemoglobin of at least 20 g/L or bleeding leading to transfusion of 2 or more units of packed red blood cells according to the definition of the International Society on Thrombosis and Haemostasis

  4. Clinically relevant non-major bleeding

    Time frame: During hospitalization (an average of 7 days) and up to 90 days of initial hospital admission

    Clinically relevant non-major bleeding, defined as overt bleeding that does not meet criteria for major bleeding but is associated with a medical intervention, unscheduled physician contact (visit or telephone call), or pain or impairment of activities of daily life

  5. Patient autonomy in the activities of daily living

    Time frame: At discharge (an average of 7 days after initial hospital admission) and at 90 days after admission

    Patient autonomy in the activities of daily living as assessed by the modified Barthel Index

  6. Length of hospital stay

    Time frame: within 90 days of initial hospital admission

    Length of hospital stay, defined as the time/date of discharge minus time/date of admission at the hospital ward

  7. Subsequent hospitalizations

    Time frame: Within 90 days of initial hospital admission

    Subsequent hospitalization, defined as hospital readmissions

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • Centre Hospitalier Universitaire Vaudois
  • University Hospital, Geneva
  • University of Bern

Registry information

Official study title

Risk Stratification for Hospital-Acquired Venous Thromboembolism in Medical Patients: a Prospective Cohort Study

Acronym: RISE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 19, 2020
Registry last updated
Apr 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.